Senior Clinical Specialist
- Manage and support assigned clinical sites across study start-up, monitoring, and close-out activities.
- Partner with Clinical Operations and Study Leadership to drive site performance, enrollment, and study milestones.
- Ensure studies are conducted in accordance with protocols, GCP, ICH guidelines, and regulatory requirements.
- Oversee site documentation, TMF/ISF maintenance, investigational product accountability, and study reporting.
- Collaborate with cross-functional teams including Medical Affairs, Regulatory, Quality, Data Management, and Pharmacovigilance.
- Experience in clinical research as a CRA, Senior CRA, Clinical Specialist, or similar clinical operations role.
- Strong knowledge of GCP, ICH guidelines, on-site monitoring practices, and site management.
- Experience supporting study start-up, enrollment, monitoring oversight, and close-out activities.
- Ability to work independently while managing multiple priorities in a fast-paced environment.
- Strong communication, relationship-building, and problem-solving skills.
- The opportunity to work directly with clinical leadership and contribute to high-impact clinical programs.
- Exposure to both operational and strategic aspects of global clinical development.
- A collaborative environment where your input is valued and your work has visible impact.
- Career growth opportunities within an expanding clinical organization.
- Hybrid work environment with the ability to work closely alongside cross-functional teams.
FAQs
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